Karen has over 30 years of experience in the biopharma industry, in a variety of commercial, medical and strategic consulting roles. She began her career in commercial leadership but moved into the unique area of Expanded Access Programs (EAP) in 2010 when she joined Clinigen, a UK based EAP service provider. In this role, she led the efforts to partner with Pharma and Biotech to develop and implement global early access solutions for patients in need, with a heavy emphasis on rare diseases and oncology access programs. In 2019, she joined Alnylam Pharmaceuticals as Senior Director, Medical Affairs, Early Access and Global Diagnostics. In this role, she has oversight of strategy, implementation and daily operations for all early access/compassionate use programs across the portfolio. In addition, she oversees the Alnylam sponsored genetic and biomarker testing programs worldwide. She is a co-author of the Global Guide to Compassionate Use, a 64-country compendium of regulations and requirements for early access and compassionate use programs worldwide. Karen graduated with honors from the University of Akron with a BSc in Biological Sciences.
Experienced panelists will share their experiences in designing, operating and closing out EAPS, with an in depth look at the success and failures encountered along the way. To be moderated by an expert EAP Ethicist that can provide additional context and situational learnings from her experience supporting a vast number of small and large pharmaceutical companies running EAPs.